Enfiera 100mg

Enfiera 100mg is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Enfiera has an approximate molecular weight of 145 kD. Enfiera has a binding affinity for the CD20 antigen of approximately 8.0 nm.
Enfiera is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product.
Enfiera 100mg is an anticancer medicine which prevents the growth and spread of cancer cells in the body.
Enfiera 100mg with steroid regimen combination is given for the treatment of some rare disorders which cause blood vessels and other tissues inflammation in the body.

Rituximab

Enfiera

100mg

Biochem pharma




Indicated for

Enfiera 100mg and hyaluronidase human injection are used as alone or concomitant use with other drugs to treat some types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia (cancer start in WBC).
Enfiera 100mg injection concomitant use with methotrexate (Otrexup, Rasuvo, Xatmep, others) is also used for the treatment rheumatoid arthritis symptoms in adults that have been already treated with a some type of drug knowns as tumor necrosis factor (TNF) inhibitor. Enfiera 100mg is a type in a classification of drugs called monoclonal antibodies.
Enfiera 100mg is indicated to killing cancer cells to treat NHL, CLL, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis by preventing the activity of the immune system parts which can injury the joints, veins, and other blood vessels and cause organs (heart and lungs) damage.

Mechanism of action

Rituximab is belonging to a classification monoclonal antibody which aim the CD20 antigen declare on the surface of pre-B and mature B-lymphocytes. Upon connecting to CD20, rituximab intercedes B-cell lysis. Probably mechanisms of cell lysis contain complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC). B cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and analog to chronic synovitis. In this setting, B cells may be action at multiple sites in the autoimmune/inflammatory process, involving through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T-cell activation, and/or proinflammatory cytokine production.



ADME PROPERTIES

Not available

volume of distribution is 3.1 L There is no human plasma level

Enfiera 100mg metabolized by human antimurine antibody production.

not available The drug elimination of half-life of NHL is 22 days and for RA is 18.0 days, GPA and microscopic polyangiitis is 23 days.




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drug
Brand Enfiera
Ingredients Rituximab
Strength 100mg
Manufactured Biochem pharmaceuticals Industries
Rating

Dosage and administration

Enfiera injection is generally used to given only via intravenous infusion not by IV push or bolus.
Prior to Each Infusion the Drug Is Premediate
First infusion: Initial treatment rate of 50 mg/hr is administer, in not showing infusion toxicity, rate increased up to 50 mg/hr. increments at intervals of 30 min and max of 400 mg/hr.
Successive infusion: starting at rate of 100 mg/hr., in not showing infusion toxicity, rate increased up to 100 mg/hr. increments at intervals of 30 min and max of 400 mg/hr.
While consolidation with CHOP chemotherapy the injection Enfiera has not been given. Hence Premedication with corticosteroids must be considered.

CHRONIC LYMPHOCYTIC LEUKEMIA

Prior to starting of FC chemotherapy, dose usual given is 375 mg/m2 followed 100 mg/m2 on day 1 of 2-6 cycles every 28 days.

RHEUMATOID ARTHRITIS

When combination of Enfiera injection with methotrexate is administrated.
Enfiera injectiongiven as two doses of 100mg IV infusion 2 weeks separated.
When glucocorticoids administered as methylprednisolone 100mg IV
Subsequent course based on clinical evaluation must administer every 24 weeks, but not early than every 16 weeks.

LOW GRADE OR FOLLICULAR NON-HODGKINS LYMPHOMA

The drug Dose is 375 mg/m2 as an IV infusion.
Once weeks for 4 or 8 doses administrated for Relapsed treatment
Once weekly for 4 doses administrated for Retreatment for relapsed.
Previously untreated: administer on day 1 of each cycle of chemotherapy, up to 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Enfiera 100mg in combination with chemotherapy completed then administer 8weeks for 12 doses as a single agent.
Once weekly for 4 doses at intervals of 6 months and max of 16 doses for Non – progression (following CVP chemotherapy completion 6 – 8 cycles):
On day 1 each cycle of chemotherapy up to 8 infusions for Diffuse Large B- cell NHL

COMPONENT OF ZEVALIN FOR TREATMENT OF NHL

The dose 250 mg/m2 of Enfiera injection within 4 hours prior to the administration of Indium-111-(In-111-) Zevalin and Yttrium-90- (Y-90-) Zevalin.
7–9 days before to Rituxan and Y-90- Zevalin administrate Rituxan and In-111-Zevalin.

GRANULOMATOSIS POLYANGITIS AND MICROSCOPIC POLYANGITIS

Enfiera injection administer Dose of 375 mg/m2 IV infusion weekly once for 4 weeks.
When Glucocorticoids given with methylprednisolone by dose of 1000 mg IV/ day for 1- 3 days and purse by oral prednisone 1 mg/kg/day are recommended for the treatment of symptoms of serious vacuities This drug should initiate within 14 days before or with the starting of Enfiera injectionand may continue during and after the 4 week course with treatment of Enfiera injectiondrug. Safety and not established for subsequent infusion.

ADMINISTRTION

Take an amount Enfiera injection is administer and diluted to final concentration of 1 mg/ml upto 4 mg/ml as infusion (containing either 0.9% Nacl or 5% dextrose in water). Gently Invert the bag and mix the solution. Discard unused drug left in vial.

OVERDOSAGE

If over dose occurs seek immediately to the emergency department or poison control help line. please consult the doctor for further clarification.

Common effects

Fever and chills (flu lik symptoms)

Less common side effects

Weakness; nausea; headache; cough;dyspnea ; pharyngitis

PRECAUTIONS

Inform the doctor if Allergic condition against Enfiera 100mg or any other medication inform your doctor.
Information about past medical history used which include in prescription, non-prescription, vitamins & supplements, nutritional products just inform the doctor.
It will harm the baby unborn, while using Enfiera 100mguse correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends.
It is unknown whether Enfiera 100mg passes into breast milk, avoid breast-feed while on Enfiera 100mg treatment.
While using Enfiera 100mg do not take any vaccination or immunization without taking advice from doctors.


Drug – drug interaction

  • Concomitant use with fludarabine or cyclophosphamide have no effects in pharmacokinetics in CLL patients.
  • Concomitant use of Enfiera 100mg with methotrexate had no effects in pharmacokinetics.

Contraindication


Enfiera drug is contraindicated to:
Hypersensitivity or murine proteins.
rheumatoid arthritis – active severe infection
Uncontrolled cardiac disease.




Pregnancy Category C There are no sufficient and well controlled studies in humans, using in pregnant women benefits by warrant use of the drug.

The drug excretion into human milk is unknown. Because the drug is a higher protein molecule and has no information is available. Women should not breast feed during Enfiera 100mg treatment and till12 months following last dose.

Store the drug at 2°C – 3°C Protected from direct sunlight and Do not freeze or shake. Discard the unused drug by asking the advice from doctor or pharmacist.

If a dose missed then have the drug soon as immediately, if next dose time reach then skip the missed dose and follow the normal schedule. Do not have extra tablet at a same time. Please consult with doctor for further details.

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